[Ip-health] Ip-health Digest, Vol 103, Issue 7/ AbbVie License

Sandeep K. Rathod rathodsandeep at gmail.com
Wed Nov 14 18:20:41 PST 2018


I believe that another issue that merits consideration in the Glecaprevir/
Pibrentasvir License is the field restriction.

In my reading, I believe that generic companies cannot add/ substitute new/
alternative HCB drugs to make new fixed drug combinations  - something that
happened very quickly with the Gilead license.


On Thu, 15 Nov 2018 at 1:31 AM, <ip-health-request at lists.keionline.org>

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>    1. MPP-AbbVie License on Glecaprevir and Pibrentasvir (Baker, Brook)
> ----------------------------------------------------------------------
> Message: 1
> Date: Tue, 13 Nov 2018 23:36:06 +0000
> From: "Baker, Brook" <b.baker at northeastern.edu>
> To: IP-health <ip-health at lists.keionline.org>
> Subject: [Ip-health] MPP-AbbVie License on Glecaprevir and
>         Pibrentasvir
> Message-ID: <BCFA85AA-9005-40FB-B3D8-EDD6E69BBD6E at northeastern.edu>
> Content-Type: text/plain; charset="utf-8"
> MPP-AbbVie License on Glecaprevir and Pibrentasvir (G/P):  Backtracking on
> Geographic Coverage but with Options for Oppositions, Compulsory Licenses,
> and Negotiated Territorial Expansion
> Professor Brook K. Baker
> Nov. 13, 2018
> AbbVie and the Medicines Patent Pool have negotiated a roylty-free
> licensing and sublicensing agreement on a priority hepatitis C direct
> acting antiviral, glecaprevir and pibrentasvir (G/P).  This G/P combo is
> recommended by the WHO as a pan-genotypic adult first-line regimen with
> ongoing Phase 3 trials for adolescents and children.  G/P has a high
> resistance barrier and the shortest treatment duration of any HCV regimen
> to date.
> The main drawback of the MPP-AbbVie license is its relatively limited
> geographic scope ? particularly its exclusion of India, a high burden
> country with a significant population of people living with HCV.  Not only
> are there fewer countries and territories included in the license (95 and 4
> respectively) than in previous DAA licenses (Table 1), but the percentage
> of the global population living with HCV covered ?  47.5% - is lower than
> Gilead?s bilateral license for sofosbuvir (62.3%) and BMS?s license for
> daclatasvir (54.3%).  Consistent with previous licenses, AbbVie prioritizes
> exclusion of so-called pharmerging markets and upper-middle-income markets,
> presumably reserving those markets for higher margin brand sales in both
> private and public sector markets.  The exclusion of countries with more
> capacity to finance reasonably priced HCV elimination strategies shrinks
> the overall market for generic G/P, reduces economies-of-scale for generic
> producers, and thus undermines treatment and elimination strategies in
> licensed territories as well.  As another negative, the license restricts
> production to companies located within the territory plus India (a
> manufacturing country only).
> The patent situation in India and excluded territories is important.
> There are five relevant patents filed on G, P, and G/P in India, one of
> which involving pibrentasvir is being opposed by I-MAK and Third World
> Network.  A first examination report on that application, since amended,
> detailed multiple grounds for denying a patent. If oppositions are expanded
> to the other four applications, if they are all successful, and if AbbVie
> does not unduly extend evaluation of its patent applications via
> substitutions, selection, amended or protracted appeals, then Indian
> generic companies would eventually be permitted to supply India and other
> non-territories where no granted patent is in force.  Thus, the MPP
> licenses accomplishes some ?wholesale? work in facilitating generic entry
> and competition in 99 countries and territories while complementary
> oppositions open up opportunities some excluded territories as well since
> the license allows supply to countries and territories if no granted patent
> will be infringed.  Unfortunately, G/P appears to be very widely patented
> in LMICs, with 30 out of 32 extra-territorial LMICs in the MedsPAL database
> reporting granted and pending patents (Table 2).
> http://www.medspal.org/?product_standardized_name=Glecaprevir/Pibrentasvir%20100/40%20mg.
> On the plus side, there is some possibility that the MPP will be able to
> convince AbbVie to expand the licensed territory, including in India, while
> generic licensee develop and registered the licensed product.  Even if
> AbbVie does not expand the licensed territory, countries where patents are
> in effect still have the option to issue compulsory licenses and to be
> lawfully supplied by generic sublicensees.
> Table 1:  Countries and Territories Included in the License
> Afghanistan, Angola, Antigua and Barbuda, Bangladesh, Belize, Benin,
> Bhutan, Bolivia, Botswana, Burkina Faso, Burundi, Cambodia, Cameroon, Cape
> Verde, Central African Republic, Chad, Comoros, Congo, Cook Island, Co?te
> d?Ivoire, Democratic Republic of the Congo, Djibouti, Dominica, Egypt,
> Equatorial Guinea, Eritrea, Ethiopia, Fiji, Gabon, Gambia, Georgia, Ghana,
> Grenada, Guadeloupe, Guinea, Guinea-Bissau, Guyana, Haiti, Indonesia,
> Jordan, Kenya, Kiribati, Laos, Lesotho, Liberia, Libya, Madagascar, Malawi,
> Maldives, Mali, Marshall Islands, Mauritania, Mauritius, Micronesia,
> Morocco, Mozambique, Myanmar, Namibia, Nauru, Nepal, Niger, Nigeria, Niue,
> Pakistan, Palau, Papua New Guinea, Philippines, Rep., Reunion Islands,
> Rwanda, Saba, Saint Eustatius, Saint Kitts and Nevis, Saint Lucia, Saint
> Vincent & the Grenadines, Samoa, Sao Tome and Principe, Senegal,
> Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South
> Sudan, Sri Lanka, Suriname, Swaziland, Tanzania, Timor-Leste, Togo,
> Tunisia, Turkmenistan, Tuvalu, Uganda, Vanuatu, Vietnam, West Bank & Gaza,
> Yemen, Zambia, Zimbabwe
>             Countries in bold have filed or granted patents
> Table 2:  LMICs with Granted or Pending Patents Excluded from the License
> (MedsPAL Nov. 13, 2018)
> Albania, Armenia, Azerbaijan, Belarus, Bosnia & Herzegovina, Brazil,
> China, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, India,
> Kazakhstan, Kyrgyz Republic, Macedonia, Malaysia, Mexico, Moldova,
> Mongolia, Montenegro, Paraguay, Peru, Russia, Serbia, Tajikistan, Thailand,
> Turkey, Ukraine, Venezuela
> *Nicaragua and El Salvador listed at having no relevant patent filed
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